Spinal stabilization system with rigid and flexible elements

ABSTRACT

A spinal stabilization system generally comprises first and second anchor members configured to be secured to first and second vertebrae within a patient&#39;s body, a flexible element secured to the first anchor member, and a rigid element secured to the second anchor member. An end portion of the rigid element is coupled to an end portion of the flexible so that the system is able to provide both rigid and dynamic stabilization. The coupling is maintained even if the flexible element relaxes after a period of time within the patient&#39;s body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/241,696, filed Sep. 23, 2011, which is a continuation of U.S. patentapplication Ser. No. 11/688,961, filed on Mar. 21, 2007, now U.S. Pat.No. 8,057,516, which issued Nov. 15, 2011, the entire disclosure ofwhich is incorporated herein by reference.

TECHNICAL FIELD

This invention relates to spinal stabilization systems, and moreparticularly to such systems including both a rigid element and aflexible element.

BACKGROUND

The spinal column is a highly complex system of bones and connectivetissues that provides support for the body and protects the delicatespinal cord. The spinal column includes a series of vertebrae stackedone on top of the other, each vertebral body including an inner orcentral portion of relatively weak cancellous bone and an outer portionof relatively strong cortical bone. The vertebrae in the cervical,thoracic, and lumbar regions of the spine are separated byintervertebral discs, which serve as cushions between adjacent vertebraeto dampen compressive forces experienced by the spine. A vertebral canalcontaining the spinal cord is formed by the intervertebral foramen ofthe vertebrae. In spite of the complexities, the spine is a highlyflexible structure, capable of a high degree of curvature and twist innearly every direction. For example, the kinematics of the spinenormally includes flexion, extension, rotation, and lateral bending.

There are many types of conditions that can lead to significant pain andaffect movement of the spine, including spinal disorders such asscoliosis (abnormal lateral curvature of the spine), kyphosis (abnormalforward curvature of the spine, usually in the thoracic spine), excesslordosis (abnormal backward curvature of the spine, usually in thelumbar spine), and spondylolisthesis (forward displacement of onevertebra over another, usually in a lumbar or cervical spine), as wellas conditions caused by abnormalities, disease, or trauma, such asruptured or slipped discs, degenerative disc disease, fracturedvertebra, and the like. In addition to causing pain, these conditionsmay also threaten the critical elements of the nervous system housedwithin the spinal canal.

One of the most common methods for treating these conditions is toimmobilize a portion of the spine to allow treatment. Traditionally,immobilization has been accomplished by rigid stabilization. Forexample, in a conventional spinal fusion procedure, a surgeon restoresthe alignment of the spine or the disc space between vertebrae byinstalling a rigid fixation rod between pedicle screws secured toadjacent vertebrae. Bone graft is placed between the vertebrae, and thefixation rod cooperates with the screws to immobilize the two vertebraerelative to each other so that the bone graft may fuse with thevertebrae.

Dynamic stabilization has also been used in spinal treatment procedures.Dynamic stabilization does not result in complete immobilization, butinstead permits enhanced mobility of the spine while also providingsufficient stabilization to effect treatment. One example of a dynamicstabilization system is the Dynesys® system available from Zimmer, Inc.of Warsaw, Ind. Such dynamic stabilization systems typically include aflexible spacer positioned between pedicle screws installed in adjacentvertebrae of the spine. Once the spacer is positioned between thepedicle screws, a flexible cord is threaded through a channel in thespacer. The flexible cord is also secured to the pedicle screws by ahousing and set screw, thereby retaining the spacer between the pediclescrews while cooperating with the spacer to permit mobility of thespine.

In some instances, it is desirable to immobilize a portion of the spineusing a rigid stabilization system without significantly limiting themobility or increasing the stress on nearby areas of the spine. Althoughcombining the rigid stabilization system with a dynamic stabilizationsystem would help achieve this objective, there are several challengesassociated with doing so. Specifically, there are several challengesassociated with combining a flexible element, such as a braided polymercord, with a rigid element, such as a rigid fixation rod, in a singleconstruct. The cord and rod are ideally connected or coupled to eachother before or during a surgical procedure. But the stiffness of theflexible element is often designed to decrease after placement into apatient's body and as treatment occurs to provide increased range ofmotion. Therefore, a spinal stabilization system in which the rigidelement remains sufficiently coupled to the flexible element after this“relaxation” is highly desirable.

SUMMARY

This invention provides a system or construct incorporating both a rigidelement and flexible element to stabilize a portion of the spine. Thesystem generally includes first and second anchor members, which may bepedicle screw assemblies, configured to be secured to first and secondvertebrae within a patient's body. The rigid element is secured to thefirst anchor member, while the flexible element secured to the secondanchor member. Respective end portions of the rigid and flexibleelements are coupled to each other in a manner that securely retainstheir connection, even after the system has been positioned within thepatient's body for an extended period of time.

In some embodiments, the end portion of the flexible element is receivedover the end portion of the rigid element. For example, the flexibleelement may be a cord constructed from polymer fibers braided over theend portion of the rigid element. To further facilitate retaining thecord on the rigid element, the fibers may be ultrasonically cut and/orultrasonically welded to an enlarged ball tip of the rigid element. Suchan arrangement increases the amount of surface area in contact betweenthe cord and the rigid element and makes it difficult to pull the cordoff the rigid element. A compression-fit collar may also be receivedover the end portion of the cord so that the fibers are gripped betweenthe ball tip of the rigid element and the collar.

In other embodiments, the end portion of the rigid element includes anaxial bore that receives the end portion of the flexible element. Theaxial bore extends at least partially into the rigid element from an endsurface and is shaped to retain an end portion of the flexible elementtherein. For example, the end portion of the flexible element mayinclude an enlarged section having a first diameter and the axial boremay include a restricted or tapered portion having a second diameterless than the first diameter. The enlarged section of the flexibleelement may be formed by positioning an insert or plug into the endportion of the flexible element. The restricted portion of the axialbore may be incorporated into the shape of the bore at the time ofmanufacture or may be formed by swaging a portion of the rigid element.

If desired, the end portion of the rigid element with the axial bore maybe received in a housing of a vertebral anchor, such as a pedicle screwassembly. One or more openings extend through an outer surface of therigid element and into the axial bore. A pin is press-fit into theopening by means of a hand press or by tightening a set screw thatsecures the rigid element within the housing of the pedicle screwassembly. Because the pin extends into the axial bore, it applies acompression force to the end portion of the flexible element received bythe bore. This compression force retains the end portion of the flexibleelement within the bore.

By virtue of the foregoing, a spinal stabilization system thateffectively incorporates aspects of both rigid and dynamic stabilizationis provided. The different manners of coupling the rigid element to theflexible element are each designed so that the coupling is maintainedeven after relaxation of the flexible element over time.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate exemplary embodiments of theinvention and, together with a general description of the inventiongiven above, and the detailed description given below, serve to explainthe principles of the invention.

FIG. 1 is a partial side elevational view showing a spinal stabilizationsystem including both a rigid element and a flexible element securedwithin a patient's body;

FIG. 2 is a schematic view showing how the rigid and flexible elementsof FIG. 1 may be coupled together according to one embodiment of theinvention;

FIG. 3 is a side elevational view, partially in cross-section, showinghow the rigid and flexible elements of FIG. 1 may be coupled togetheraccording to another embodiment of the invention;

FIG. 4 is a side elevational view, partially in cross-section, showinghow the rigid and flexible elements of FIG. 1 may be coupled togetheraccording to another embodiment of the invention;

FIG. 5 is cross-sectional view showing how the rigid and flexibleelements of FIG. 1 may be coupled together according to anotherembodiment of the invention;

FIG. 6 is a cross-sectional view showing how the rigid and flexibleelements of FIG. 1 may be coupled together according to anotherembodiment of the invention;

FIG. 6A is a perspective view of a portion of the rigid element shown inFIG. 6;

FIG. 7 is a perspective view showing a portion of the flexible elementof FIG. 1 according to another embodiment of the invention;

FIG. 8 is a cross-sectional perspective view showing how the flexibleelement of FIG. 6 may be coupled to the rigid element of FIG. 1;

FIG. 9 is a cross-sectional side view showing the rigid and flexibleelements of FIG. 1 according to another embodiment of the invention;

FIG. 10 is a perspective view showing how the rigid and flexibleelements of FIG. 9 may be coupled together; and

FIG. 11 is a partial side elevational view, partially in cross-section,showing how the rigid and flexible elements of FIG. 1 may be coupledtogether according to another embodiment of the invention.

DETAILED DESCRIPTION

FIG. 1 shows one embodiment of a spinal stabilization system orconstruct 10 according the invention within a patient's body. Thestabilization system 10 includes first, second, and third anchor members12,14,16 secured to respective first, second, and third vertebrae 18,20, 22 within the patient's body. The anchor members 12,14,16 may be anytype of anchor such as a screw or hook designed to cooperate with arigid element 24 or a flexible element 26 to stabilize a portion of thespine. For example, in the embodiment shown in FIG. 1, the anchormembers 12,14,16 are pedicle screw assemblies each having a screw body30, a housing or retainer 32 coupled to the screw body 30, and a setscrew 34. Each housing 32 receives the rigid element 24 or the flexibleelement 26, which are secured to the associated housing 32 by one of theset screws 34. One example of this type of pedicle screw arrangement isthe Optima® Spinal Stabilization System available from Zimmer, Inc. ofWarsaw, Ind.

The rigid element 24 and the flexible element 26 each extend between twoor more of the pedicle screw assemblies. The rigid element 24 may be ametal rod, such as those commonly used in rigid spinal fixationprocedures, while the flexible element 26 may be a cord, such as thosecommonly used in dynamic stabilization procedures. For example, theflexible element 26 may be constructed from braidedpolyethylene-terephalate (PET) fibers or other braided polymer fibers. Aflexible spacer 36 is received over the flexible element 26 to provideadditional support during movement of the spine in some embodiments.

As shown in FIG. 1, the rigid element 24 is coupled to the flexibleelement 26 between the first and second anchor members 12,14. Such anarrangement enables the overall system or construct 10 to combine thefeatures of both rigid stabilization and dynamic stabilization. Inparticular, the rigid element 24 enables the system 10 to rigidlyimmobilize a desired area of the spine to promote fusion or othertreatment in a desired area, while the flexible element 26 providesadditional stabilization without significantly increasing the stress onnearby vertebrae or compromising mobility. The rigid and flexibleelements 24, 26 may be coupled to each other in a variety of differentmanners, examples of which will be described below with reference toFIGS. 2-11.

For example, FIGS. 2 and 3 illustrate embodiments in which an endportion 50 of a braided cord 52 is received over an end portion 54 of arigid fixation rod 56. The end portion 50 of the cord 52 is retained onthe end portion 54 of the rod 56, which may be achieved by braiding orweaving the fibers of the cord 52 over the end portion 54. Once thisstep is complete, the region where the cord 52 overlaps the rod 56 isheat treated in a manner that promotes intimate chemical and physicalbonding of the cord 52 to the rod 56. For example, the cord 52 may beultrasonically welded to the rod 56. Such an arrangement results in thecord 52 being coupled to the rod 56 prior to implantation withoutplacing meaningful stresses on the cord 52 and without the system 10requiring additional components.

Additionally, as shown in FIG. 3, in some embodiments the end portion 54of the fixation rod 56 may further include an enlarged ball tip 58. Oncethe cord 52 is braided over the ball tip 58, the end portion 50 of thecord 52 is cut at location on the rod 56 spaced from the ball tip 58(i.e., where the cord 52 has a smaller diameter than that of the balltip) by ultrasonic cutting. The ultrasonic cutting and/or weldingresults in the fiber ends joining together so that the end portion 50includes a permanent diameter smaller than the ball tip 58, therebypreventing the cord 52 from fraying and further retaining it on the endportion 54 of the fixation rod 56. The relatively large amount ofcontact area between the cord 52 and the rod 56 helps distribute any preor postoperative loads on the cord 52, which in turn minimizes theeffects of changes in those loads resulting from post-operativerelaxation of the cord 52 or other conditions.

If desired, a collar 60 may also be compression-fitted around the endportion 50 of the cord 52 to further retain the cord 52 on the fixationrod 56. When tension is applied to the cord 52, the collar 60 cooperateswith the ball tip 58 to provide a gripping force. The collar 60 includesa polished end surface 62 configured to confront the spacer 36 (FIG. 1),with the end surface 62 optionally defined by a radially extendingflange 64. Those skilled in the art will appreciate that the collar 60may also be designed to interact with one of the pedicle screwassemblies.

Rather than being received over the end portion of the rigid element 24,the flexible element 26 may be received and retained within a portion ofthe rigid element 24. For example, FIG. 4 illustrates an embodiment inwhich an end portion 70 of a fixation rod 72 includes an axial bore 74extending from an end surface 76. An end portion 78 of a flexible cord80 is received in the axial bore 74. To retain the cord 80 in the bore74, the end portion 70 of the fixation rod 72 is swaged (i.e.,cold-worked) about its circumference at one or more locations designatedby 82. The 360 degree swages 82 place the cord 80 into high,radially-symmetric compression so that it cannot be easily pulled out ofthe axial bore 74. The swages 82 also provide the end portion 70 of thefixation rod 72 with a rib-like appearance.

FIG. 5 also illustrates an embodiment of the spinal stabilization system10 in which a fixation rod 90 is swaged to retain an end portion 92 of aflexible cord 94 within an axial bore 96. Specifically, the fixation rod90 terminates in an end surface 98 defined by a radially extendingflange 100. The end surface 98 may be configured to confront a spacer 36(FIG. 1) and further includes flange 102 extending distally therefromaround the opening of the axial bore 96. After the end portion 92 of thecord 94 is inserted into the axial bore 96, the distal flange 102 isswaged in a radially inward direction to define a restricted portion 104of the axial bore 96. The restricted portion 104 has a diameter lessthan that of the end portion 92 of the cord 94 so that the cord 94 isretained in the axial bore 96.

For this purpose, the end portion 92 of the cord 94 may include aninsert or plug 106 to define an enlarged diameter section 108. Theinsert 106 may be constructed from metal or any other biocompatiblematerial and is surrounded and retained by the end portion 92 of thecord 94. For example, after weaving fibers of the cord 94 around theinsert 106 or positioning the insert 106 in a predefined space withinthe end portion 92, the cord 94 may be ultrasonically heated while beingcompressed around the insert 106 in a mold (not shown). This ultrasonicforming process promotes bonding of the cord fibers to the insert 106and provides the cord 94 with a shape that retains the insert 106 in theend portion 92. Thus, when the end portion 92 of the cord 94 is receivedin the axial bore 96 and the distal flange 102 is swaged inwardly todefine the restricted portion 104, pulling on the cord 94 results in thecord fibers being “wedged” between the insert 106 and the restrictedportion 104. This resistance to pull-out remains effective even afterwarming and relaxation of the cord 94 within a patient's body.

An embodiment that operates upon similar principles is shown in FIGS. 6and 6A. In this embodiment, an end portion 112 of a flexible cord 114 isprovided with an insert 116 in the same manner as the previousembodiment to define an enlarged diameter section 118. A fixation rod120 having an enlarged end portion 122 includes an axial bore 124extending from an end surface 126. The axial bore 124 receives the endportion 112 of the cord 114, but includes a restricted portion 128having a smaller diameter than that of the enlarged section 118. Ifdesired, an interior surface 130 of the axial bore 124 may be tapered tohelp define the restricted portion 128 and to define a shape that moreclosely resembles that of the cord end portion 112.

In this arrangement, the cord 114 cannot be end-loaded into the axialbore 124 through an opening 132 on the end surface 126 of the fixationrod 120. Instead, the end portion 112 of the cord 114 is insertedthrough a slot 134 on the end portion 122 of the rod 120. The slot 134extends into the axial bore 124 and includes an enlarged opening 136 toaccommodate the enlarged section 118 of the cord 114, as shown in FIG.6A. Applying tension to the cord 114 after the end portion 112 isreceived in the axial bore 124 creates a wedge-like effect due to theinterference between insert 116 and the restricted portion 128. In otherwords, as with the embodiment shown in FIG. 5, the fibers of the cord114 are “wedged” between the insert 116 and the restricted portion 128to retain the cord 114 within the axial bore 124. The more tension thatis placed on the cord 114, the stronger it is gripped between the insert116 and the restricted portion 128.

The cord 114 may be inserted through the slot 134 and into the axialbore 124 prior to or even during an operation because of the pre-formedshape of the fixation rod 120. For example, during a surgical procedure,the rod 120 may first be secured to a top-loading pedicle screw 30(FIG. 1) using the housing 32 and set screw 34. After inserting the endportion 112 of the cord 114 through the slot 134 and into the axial bore124, the cord 114 may then be secured to a different pedicle screwassembly to stabilize the entire construct 10. Because the cord 114 isnot put under any stress prior to insertion into the patient's body,concerns about stress relaxation during storage are avoided.Additionally, if further surgical procedures are later required toeffect treatment, the cord 114 may be easily replaced without requiringremoval of the fixation rod 120. This is particularly advantageous whenseeking to modify the amount of dynamic stabilization provided by theentire construct 10 by replacing the original cord 114 with a differentone.

FIGS. 7 and 8 illustrate another embodiment in which a cord 140 may becoupled to a rigid element 142 between the first and second anchormembers 12,14 (FIG. 1). In this embodiment, the cord 140 is providedwith a preformed shape. For example, the cord 140 may be constructedfrom polymer fibers and may be ultrasonically heated while beingcompressed in a mold. This ultrasonic forming process in one embodimentresults in an end portion 144 of the cord 140 having a reduced diameterand first and second recesses 146,148.

The rigid element 142 includes an end portion 150 with an outer surface152 and an end surface 154. The end surface 154 is defined by a radiallyextending flange 156 and configured to confront the spacer 36 (FIG. 1).An axial bore 158 extends into the end portion 150 from the end surface154, and the outer surface 152 includes first and second openings orholes 160,162 extending into the axial bore 158. The axial bore 158receives the end portion 144 of the cord 140, with the first and secondopenings 160,162 aligned with the respective first and second recesses146,148. To retain the cord 140 within the axial bore 158, first andsecond fasteners 164,166 are inserted through the respective first andsecond openings 160,162 until they are received in the respective firstand second recesses 146,148. Because the first and second recesses146,148 are permanently formed in the end portion 144 of the cord 140,relaxation of the cord 140 has minimal or no affect on the engagementbetween the first and second recesses 146,148 and the first and secondfasteners 164,166.

The fasteners 164,166 shown in FIG. 8 are pins that are press-fit intothe first and second openings 160,162. It will be appreciated, however,that a wide variety of other types of fasteners (screws, rings, clips,etc.) may be secured within the first and/or second openings 160,162 toretain the end portion 144 of the cord 140 within the axial bore 158. Itwill also be appreciated that only one fastener may be used to retainthe cord 140 and that the axial bore 158 of the rigid element 142 maybeshaped with features adapted to cooperate with the preformed shaped ofthe cord 140. For example, rather than including the second opening 162,the rigid element 142 may be machined to define a protrusion (not shown)in the axial bore 158 at the same location. The protrusion wouldcooperate with the second recess 148 to retain the end portion 144 ofthe cord 140 in the axial bore 158. The end portion 144 of the cord 140and axial bore 158 of the rigid element 142 may therefore be shaped in avariety of different manners to achieve this type of relationship.

FIGS. 9-11 illustrate embodiments of the system 10 shown in FIG. 1 inwhich the rigid member 24 is shaped to cooperate with one of the pediclescrew assemblies 12,14,16 to retain the flexible element 26 within aportion thereof. The housings 32 and set screws 34 shown in FIG. 1 havea different configuration in the embodiments shown in FIGS. 9-11 andwill be indicated with prime marks (′) in the description below.

To this end, FIGS. 9 and 10 illustrate a rigid element 172 having an endportion 174 received in the housing 32′ of a pedicle screw assembly. Theend portion 174 includes an end surface 176 configured to confront aspacer 36 (FIG. 1), an axial bore 178 extending from the end surface176, an outer surface 180, and first and second openings 182,184 on theouter surface 180 extending into the axial bore 178. The first opening182 has a relatively small diameter and receives a needle member 186,while the second opening 184 has a larger diameter and receives a pin188. An interference fit may be provided between the needle member 186and the first opening 182 and the pin 188 and the second opening 184.

A flexible element 190, such as a cord constructed from braided polymerfibers, includes an end portion 192 received in the axial bore 178. Theflexible element 190 is initially secured within the axial bore 178 byinserting the needle member 186 through the first opening 182. Themanufacturer typically accomplishes this step so that the construct ispre-assembled with the flexible element 190 coupled to the rigid element172 prior to delivery to the customer. The needle member 186 engages thecord 190 proximate an end 194, which serves little function in terms ofultimately providing stabilization once in a patient's body.

The pin 188 may also be partially inserted into the second opening 184by the manufacturer, but is not advanced far enough to place anyappreciable stresses on the cord 190. Instead, the final pressing of thepin 188 is accomplished prior to use with a hand press (not shown) orother similar tool. The pin 188 is ideally advanced through the secondopening 184 until a top surface 196 of the pin 188 becomes substantiallyflush with the outer surface 180 of the rigid element 172. Such anarrangement prevents the pin 188 from interfering with the operation ofthe set screw 34′, which secures the rigid element 172 to the housing32′ of the pedicle screw assembly.

The pin 188 compresses the flexible element 190 within the axial bore178 to retain the flexible element 190 therein. A protrusion 198, suchas a bump or rib, may be provided in the axial bore 178 opposite thesecond opening 184 so that the flexible element 190 is gripped betweenthe pin 188 and the protrusion 198. The pin 188 applies sufficient forceto securely retain the cord 190 even after relaxation once inserted intoa patient's body. Although only a press-fit pin is shown, any type offastener capable of applying forces to the cord 190 may be used instead.

FIG. 11 shows a similar embodiment having a pin 210 for retaining an endportion 212 of a flexible element 214 within an axial bore 216 of arigid element 218. As with the previous embodiment, the axial bore 216is positioned within an end portion 220 of the rigid element 218received in the housing 32′ of a pedicle screw assembly and has an endsurface 222 configured to confront the spacer 36 (FIG. 1). An opening224 on an outer surface 226 of the end portion 220 extends into theaxial bore 216 and is aligned with the set screw 34′ received in thehousing 32′. The set screw 34′ normally engages internal threads 230 tosecure the end portion 220 of the rigid element in a socket defined bythe housing 32′. To accommodate for the pin 210, the housing 32′ furtherincludes first and second tabs 234, 236 extending upwardly. Each of thefirst and second tabs 234, 236 includes internal threads 238 as well.

In use, the end portion 212 of the flexible element 214 is inserted intothe axial bore 216. The pin 210 is then inserted into the opening 224and the set screw 34′ is advanced along the internal threads 238 of thefirst and second tabs 234, 236 until it contacts a top surface 240 ofthe pin 210. To secure the flexible element 214 within the axial bore216, the set screw 34′ is further advanced to engage the internalthreads 230 of the housing 32′ and to push the pin 210 into the opening224. The set screw 34′ is advanced until the top surface 240 of the pin210 is substantially flush with the outer surface 226 of the rigidelement 218. In this position, the pin 210 applies a sufficientcompression force to retain the end portion 212 of the flexible element214 within the axial bore. One or more protrusions 242 or the like maybe provided within the axial bore 216 to help grip the flexible element214, much like the previous embodiment.

Thus, the flexible element 214 may be secured to the rigid element 218without any additional tools. The same tool normally used to secure theset screw 34′ is used to advance the pin 210 into the axial bore 216.Although the pin 210 and set screw 34′ are shown as separate components,they may alternatively be integrally formed as a single component. Thefirst and second tabs 234, 236 may also be configured to be removed fromthe housing 32′ after the set screw 34′ is completely advanced. Inparticular, the first and second tabs 234, 236 serve to distribute theforce applied to the housing 32′ while tightening the set screw 34′ witha screwdriver or other tool. The tabs 234, 236 may be frangiblyconnected or otherwise separable from the housing 32′ of the pediclescrew assembly. Once the set screw 34′ is advanced so that it onlyengages the internal threads 230 of the housing 32′, the first andsecond tabs 234, 236 may be broken off from the housing 32′ and removed.

While the invention has been illustrated by the description of one ormore embodiments thereof, and while the embodiments have been describedin considerable detail, they are not intended to restrict or in any waylimit the scope of the appended claims to such detail. Additionaladvantages and modifications will readily appear to those skilled in theart. For example, although the rigid element is primarily describedabove as a metal rod, those skilled in the art will appreciate that“rigid” is a relative term. To this end, the rigid element may be ametal cable and the flexible element may be a polymer cord. The cableand cord may be coupled using the techniques described above or maysimply be spliced together.

Therefore, the invention in its broader aspects is not limited to thespecific details, representative apparatus and methods, and illustrativeexamples shown and described. Accordingly, departures may be made fromsuch details without departing from the scope or spirit of the generalinventive concept.

What is claimed:
 1. A spinal stabilization system, comprising: an anchormember configured to be secured to a vertebra within a patient's body,the anchor member including: a pedicle screw body; a housing havinginternal threads; and a set screw configured to rotatably engage theinternal threads of the housing; a rigid element securable to the anchormember, the rigid element having an axial bore extending into the rigidelement and an opening on an outer surface of the rigid elementextending into the axial bore; a flexible element receivable within theaxial bore, wherein the flexible element is securable within the axialbore; and a fastener receivable within the opening and configured toretain the flexible element in the axial bore; wherein the set screwengages the internal threads of the housing and rotation of the setscrew advances the fastener in the opening of the rigid element intoengagement with the flexible element.
 2. The spinal stabilization systemof claim 1, wherein the fastener is a separate component from the setscrew.
 3. The spinal stabilization system of claim 1, wherein thefastener is integrally formed with the set screw as a single component.4. The spinal stabilization system of claim 1, wherein the housingincludes first and second tabs separable from the housing.
 5. The spinalstabilization system of claim 4, wherein the first and second tabs arefrangibly connected to the housing.
 6. The spinal stabilization systemof claim 1, wherein the rigid element includes a protrusion extendinginto the axial bore.
 7. The spinal stabilization system of claim 6,wherein the protrusion extends into the axial bore opposite the opening.8. The spinal stabilization system of claim 1, wherein the rigid elementis receivable within the housing of the anchor member in a directiontransverse to the axial bore.
 9. A spinal stabilization devicecomprising: a rigid member comprising: an elongate rigid elementextending in a longitudinal direction; an end portion connected to theelongate rigid element, the end portion being shaped to be receivedwithin a housing of a pedicle anchor member; an axial bore extendinginto the end portion in a longitudinal direction; and an openingextending into the end portion to intersect the axial bore; a flexiblemember configured to be positioned within the axial bore to extendacross the opening; and a fastener configured to radially slide into theopening and engage the flexible member.
 10. The spinal stabilizationdevice of claim 9, wherein the opening extends transverse to the axialbore.
 11. The spinal stabilization device of claim 9, wherein the endportion includes flange members configured to engage the housing of thepedicle anchor member and the bore is located longitudinally between theflange members.
 12. The spinal stabilization device of claim 11, whereina top surface of the end portion is flat across an entirety of the endportion including the flange members.
 13. The spinal stabilizationdevice of claim 12, wherein the flange members extend below and to theside of the end portion and do not extend above the top surface.
 14. Thespinal stabilization device of claim 12, wherein the fastener isconfigured to extend above the top surface when fully engaged with theflexible member.
 15. The spinal stabilization device of claim 9, whereinthe end portion includes a protrusion extending within the axial boreopposite the opening.
 16. The spinal stabilization device of claim 9,further comprising a housing into which the rigid member is configuredto be positioned; and a set screw configured to engage thread of thehousing to advance the fastener into the opening of the rigid member andinto engagement with the flexible member.
 17. The spinal stabilizationdevice of claim 9, further comprising a needle connected to the endportion to extend into the axial bore to engage the flexible member.